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Integra LifeSciences Corp. recalls Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable
Recalled August 3, 2016 · FDA recall Z-2296-2016 · Integra LifeSciences
Hazard
The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold. · FDA Class II
Units
27 units
Sold at
Distributed in the US to the states of FL, VA, OK, CO, DC, and IN.
Description
The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
Product
Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →